Clinical trial · Interventional
Pre- or Postoperative Accelerated Radiotherapy
Feasibility Study on Pre or Postoperative Accelerated Radiotherapy (POP-ART) in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
20 non-metastasized breast cancer patients receiving neoadjuvant chemotherapy will be randomized between preop or postop RT. Patients with clinically suspicious axillary lymph nodes will receive a fine needle biopsy. Patients receiving postop RT will receive neoadjuvant CT followed by surgery (21-28 days after CT) and adjuvant RT starting 28-35 days after surgery. Patients receiving preop RT will receive RT first, followed by CT (5-8 days after the end of RT) and surgery (21-28 days after CT). All patients will receive a clip to locate the tumor before the start of any treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- preoperative
- description
- preoperative radiotherapy
- interventionNames
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- postoperative
- description
- postoperative radiotherapy
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Feasibility of preop RT will be assessed in terms of overall treatment time
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All of the following inclusion criteria must be met: * female patients with non-metastatic breast cancer, * biopsy proven, * age ≥ 18 years, * WHO performance status 0 or 1, * using contraceptives if in reproductive age category * eligible for neo-adjuvant CT after multidisciplinary decision, * informed consent obtained, signed and dated before specific protocol procedures. Exclusion Criteria: Any one or combination of the following: * distant metastases, * inflammatory breast cancer (mastitis carcinomatosa), * multifocal tumor, * lobular carcinoma, * bilateral breast cancer, * history of cancer, with the exception of non-melanoma skin cancer, in situ cervix carcinoma * history of chemotherapy, * history of radiation treatment, * pregnant or breast feeding, or not using contraceptives if in reproductive age category * exclusion criteria for chemotherapy: * leukocytes \< 2500 * absolute neutrophil count \< 1000/µL * hemoglobine \< 8 g/dL (transfusion is allowed) * platelets \< 100 000/µl * total bilirubine \> 1.5 x maximal normal reference range * AST \> 2.5 x maximal normal reference range * ALT \> 2.5 x maximal normal reference range * creatinine \> 1.5 x maximal normal reference range * Left ventricular ejection fraction (LVEF) \< 55% * planned immediate reconstructive surgery, * conditions making toxicity evaluation difficult (e.g. skin disorders), * Amiodarone treatment in the last 6 months * patients unlikely to comply with the protocol (e.g. inability to return for follow-up visits or unlikely to complete the study).
References
Publications (0)
Data not yet available